Animation Supported Consent Before Elective Laparoscopic Cholecystectomy.

BACKGROUND: Patient understanding of surgical procedures is often incomplete at the time they are performed, invalidating consent, and exposing healthcare providers to complaints and claims of failure to inform. Remote consultations, language barriers and patient factors can hinder an effective consent pathway. New approaches are needed to support communication and shared decision-making. METHODS: Multi-language digital animations explaining laparoscopic cholecystectomy were introduced at The Royal London Hospital for patients who attended for elective surgery ( www.explainmyprocedure.com/lapchole ). Patients completed questionnaires on the day of their procedure both before and after introduction of the animations. We assessed patient-reported understanding of the procedure, its intended benefits, the possible risks, and alternatives to treatment in 72 consecutive patients, 37 before (no animation group) and after 35 after introducing the animations into the consent pathway (animation group). Patient understanding in the two groups was compared. RESULTS: The two groups were well matched in respect of age, sex and whether English was their first spoken language. The proportions of patients who reported they completely understood the procedure, its benefits, risks, and alternatives in the no animation group were 54, 57, 38 and 24% and in the animation group, 91, 91, 74 and 77%, respectively; p < 0.01 for each comparison. CONCLUSION: The integration of multi-language laparoscopic cholecystectomy video animations into the patient consent pathway was associated with substantial improvement in reported understanding of the procedure, benefits, risks, and alternatives to treatment. This approach can be applied across all surgical disciplines in a standardised manner in an era of accelerated elective work and remote consultations.

Animation supported communication on intensive care; a service improvement initiative.

Objective: COVID-19 has created unique challenges for families of patients admitted to intensive care units. Restricted visiting, language barriers and time constraints have limited communication, resulting in a lack of understanding and anxiety. We introduced digital animations to support communication and assessed the impact on families of patients admitted to intensive care. Methods: Multi-language animations explaining mechanical ventilation, (www.explainmyprocedure.com/icu) were introduced at two London intensive care units during the COVID-19 pandemic. Web-links were sent by email. Reported understanding of the treatment, its benefits, risks and alternatives was assessed among family contacts of 71 consecutive patients admitted to intensive care; 39 before the animations were introduced (no animation group) and 32 afterwards (animation group). Reported understanding in the two groups was assessed by telephone questionnaire and compared. Results: Following introduction, all relatives reported they had watched the animation. The proportions who reported complete understanding of mechanical ventilation, its benefits, risks and alternatives, in the no animation group (n = 39) were, respectively, 15%, 28%, 0% and 3% and in the animation group (n = 32), 94%, 97%, 84% and 66% (p < 0.0001 for all comparisons). Conclusion: Family use of online multi-language animations explaining mechanical ventilation is feasible, acceptable and associated with substantial improvement in understanding. The approach is not limited to mechanical ventilation, or to use in a pandemic, and has the potential to be applied to a wide range of treatment and recovery pathways on intensive care.

Potential impact of gradual reduction of fat content in manufactured and out-of-home food on obesity in the United Kingdom: a modeling study.

BACKGROUND: Manufactured and out-of-home foods contribute to excessive calories and have a critical role in fueling the obesity epidemic. We propose a 20% fat reduction in these foods. OBJECTIVES: To evaluate the potential impact of the proposed strategy on energy intake, obesity and related health outcomes in the population. METHODS: We used the National Diet and Nutrition Survey rolling program (NDNS RP) data to calculate fat and energy contributions from 46 manufactured and out-of-home food categories. We considered a gradual fat reduction-focusing on SFA-in these categories to achieve a 20% reduction in 5 years. We estimated the reduction in energy intake in the NDNS RP population and predicted the body weight reduction using a weight loss model. We scaled up the body weight reduction to the UK adult population. We estimated reductions in overweight/obesity and type 2 diabetes cases. We calculated the reductions of LDL, ischemic heart disease (IHD), and stroke deaths that could be prevented from the SFA reduction. RESULTS: The selected categories contributed to 38.6% of the population's energy intake. By the end of the fifth year, our proposed strategy would reduce the mean energy intake by 67.6 kcal/d/person (95% CI: 66.1-68.8). The energy reduction would reduce the mean body weight by 2.7 kg (95% CI: 2.6-2.8). The obesity prevalence would be reduced by 5.3% and the overweight prevalence by 1.5%, corresponding to 3.5 and 1 million cases of obesity and overweight, respectively, being reduced in the United Kingdom. The body weight reduction could prevent 183,000 (95% CI: 171,000-194,000) cases of type 2 diabetes over 2 decades. Energy from SFA would fall by 2.6%, lowering LDL by 0.13 mmol/L and preventing 87,560 IHD deaths (95% CI: 82,260-112,760) and 9520 stroke deaths (95% CI: 4400-14,660) over 20 years. CONCLUSIONS: A modest fat reduction (particularly in SFA) in widely consumed foods would prevent obesity, type 2 diabetes, and cardiovascular disease.

Animation-supported consent for urgent angiography and angioplasty: a service improvement initiative.

OBJECTIVE: Patient understanding of angiography and angioplasty is often incomplete at the time of consent. Language barriers and time constraints are significant obstacles, particularly in the urgent setting. We introduced digital animations to support consent and assessed the effect on patient understanding. METHODS: Multi-language animations explaining angiography and angioplasty (www.explainmyprocedure.com/heart) were introduced at nine district hospitals for patients with acute coronary syndrome before urgent transfer to a cardiac centre for their procedure. Reported understanding of the reason for transfer, the procedure, its benefits and risks in 100 consecutive patients were recorded before introduction of the animations into practice (no animation group) and in 100 consecutive patients after their introduction (animation group). Patient understanding in the two groups was compared. RESULTS: Following introduction, 83/100 patients reported they had watched the animation before inter-hospital transfer (3 declined and 14 were overlooked). The proportions of patients who understood the reason for transfer, the procedure, its benefits and risks in the no animation group were 58%, 38%, 25% and 7% and in the animation group, 85%, 81%, 73% and 61%, respectively. The relative improvement (ratio of proportions) was 1.5 (95% CI 1.2 to 1.8), 2.1 (1.6 to 2.8), 2.9 (2.0 to 4.2) and 8.7 (4.2 to 18.1), respectively (p<0.001 for all comparisons). CONCLUSION: Use of animations explaining angiography and angioplasty is feasible before urgent inter-hospital transfer and was associated with substantial improvement in reported understanding of the procedure, its risks and its benefits. The approach is not limited to cardiology and has the potential to be applied to all specialties in medicine.

Should fractional flow reserve follow angiographic visual inspection to guide preventive percutaneous coronary intervention in ST-elevation myocardial infarction?

AIMS: We aimed to quantify the effect of preventive percutaneous coronary intervention (PCI to non-infarct arteries) on cardiac death and non-fatal myocardial infarction (MI) in patients with ST-elevation myocardial infarction (STEMI) according to whether the decision to carry out preventive PCI was based on angiographic visual inspection (AVI alone) or AVI plus fractional flow reserve (FFR) if AVI showed significant stenosis (AVI plus FFR). METHODS AND RESULTS: Randomized trials comparing preventive PCI with no preventive PCI in STEMI without shock were identified by a systematic literature search and categorized according to whether they used AVI alone or AVI plus FFR to select patients for preventive PCI. Random effects meta-analyses and tests of heterogeneity were used to compare the two categories in respect of cardiac death and MI as a combined outcome and individually. Eleven eligible trials were identified. For cardiac death and MI, the relative risk estimates for AVI alone vs. AVI plus FFR were 0.39 (0.25-0.61) and 0.85 (0.57-1.28), respectively (P = 0.01 for difference), for cardiac death, alone the estimates were 0.36 (0.19-0.71) and 0.79 (0.36-1.77), respectively (P = 0.15 for difference), and for MI alone, 0.41 (0.23-0.73) and 0.98 (0.62-1.56), respectively (P = 0.04 for difference). CONCLUSION: In preventive PCI among STEMI patients, AVI alone achieves a ∼60% reduction in cardiac death and MI but selecting patients using FFR in AVI positive patients loses much of the benefit. Angiographic visual inspection is best used without FFR in this group of patients.

Reaching detection targets in familial hypercholesterolaemia: Comparison of identification strategies.

BACKGROUND AND AIMS: Familial hypercholesterolaemia (FH) is a common and preventable cause of premature heart attack but in most nations only a small proportion of FH-positive individuals have been identified. The aim of this study was to estimate the time to close this FH detection gap. METHODS: We developed a model to estimate the time to identify different proportions of FH in the population for three identification strategies (i) Cascade Testing (FH-mutation testing in relatives of someone with an FH mutation) (ii) Child-parent Screening (testing children for cholesterol and FH mutations during 1-year immunisation and parents of FH-positive children) and (iii) Child-parent Cascade Screening (integrating the first two methods). We used publicly available data to compare the strategies in terms of the time to identify 25%, 50% and 75% of all FH cases in the UK (current target is 25% in 5 years). For Child-parent Cascade Screening, we applied the model to other populations that have reported FH identification levels. RESULTS: In the UK, 25% of FH individuals would be identified after 47 years for Cascade Testing, 12 years for Child-parent Screening and 8 years for Child-parent Cascade Screening; 50% identification after 146, 33 and 19 years and 75% after 334, 99 and 41 years respectively. For Child-parent Cascade Screening, the times to identify 50% FH were, for Netherlands, Norway, Japan, Canada, USA, Australia/NZ, South Africa and Russia, 0, 5, 13, 15, 16, 18, 21, and 30 years respectively. CONCLUSIONS: Child-parent Cascade Screening is the fastest strategy for identifying FH in the population. The model is applicable to any country to estimate the time to close the FH detection gap (www.screenfh.com).

Current management of children and young people with heterozygous familial hypercholesterolaemia - HEART UK statement of care.

This consensus statement on the management of children and young people with heterozygous familial hypercholesterolaemia (FH) addresses management of paediatric FH in the UK, identified by cascade testing when a parent is diagnosed with FH and for those diagnosed following incidental lipid tests. Lifestyle and dietary advice appropriate for children with FH; suggested low density lipoprotein cholesterol (LDL-C) targets and the most appropriate lipid-lowering therapies to achieve these are discussed in this statement of care. Based on the population prevalence of FH as ~1/250 and the UK paediatric population, there are approximately 50,000 FH children under 18 years. Currently only about 550 of these children and young people have been identified and are under paediatric care.

Randomized Crossover Trial of Phosphate-binding Medication on Serum Phosphate Levels in Patients With Aortic Stenosis.

PURPOSE: Aortic stenosis is a common cause of valvular heart disease with no means of prevention. The recognized association between aortic stenosis and serum phosphate raises the possibility of preventing progression of the disorder by using phosphate-binding drugs, but there is uncertainty whether such treatment lowers serum phosphate levels in patients without diagnosed renal failure. This pilot study was conducted to answer this question in patients with aortic stenosis. METHODS: A randomized, double-blind, crossover trial of the phosphate-binding drug sevelamer was conducted in 72 patients. Patients were prescribed sevelamer 0.8 g (low-dose), sevelamer 2.4 g (high-dose), and matching placebo, 3 times daily with food; each regimen lasted 6 weeks and was allocated at random. Serum phosphate levels were measured at the end of each treatment period, and within-person levels were compared. FINDINGS: Sixty-one patients completed the 3 treatment periods. There was no significant difference in the mean end-treatment phosphate levels across all patients (3.38, 3.36, and 3.31 mg/dL with placebo, low-dose sevelamer, and high-dose sevelamer, respectively). Post hoc analysis showed a reduction in phosphate levels with increasing sevelamer dose in the highest baseline phosphate quartile group; a 0.3 mg/dL reduction (mean, 4.09 mg/dL with placebo, 3.95 mg/dL with low-dose sevelamer, and 3.79 mg/dL with high-dose sevelamer; Ptrend = 0.027). IMPLICATIONS: Sevelamer had no overall statistically significant effect in lowering serum phosphate levels, but a reduction was observed in patients with phosphate levels in the highest quartile group of the population distribution. This hypothesis-generating result requires confirmation in an independent study. If confirmed, a trial of sevelamer in preventing the progression of aortic stenosis may be justified in patients with high phosphate levels. ISRCTN Registry identifier: ISRCTN17365679.

Integration of child-parent screening and cascade testing for familial hypercholesterolaemia.

OBJECTIVE: To integrate child-parent screening and cascade testing into a single pathway-child-parent cascade screening (CPCS), for the identification of familial hypercholesterolaemia in the population and to estimate the number of new familial hypercholesterolaemia cases identified per child screened and the associated costs. METHODS: We applied the results from the published MRC Child-Parent Screening Study to 10,000 children, together with cascade testing first degree relatives of parents with a familial hypercholesterolaemia mutation identified by child-parent screening. We estimated the number of familial hypercholesterolaemia cases identified per child screened, the median cost per familial hypercholesterolaemia case identified and the median cost per child screened to identify one case using a range of cholesterol and familial hypercholesterolaemia mutation testing costs. We present a case study to illustrate the application of CPCS in practice. RESULTS: CPCS identifies one new familial hypercholesterolaemia case per 70 children screened at a median estimated cost of £960 per new familial hypercholesterolaemia case or £4 per child screened. CPCS identifies an average of four new familial hypercholesterolaemia cases per family. In the case study, six new familial hypercholesterolaemia cases were identified, and preventive treatment started in five, with the index child expected to start when older. CONCLUSION: CPCS for familial hypercholesterolaemia are complementary strategies. The sustainability of cascade testing relies on identifying new unrelated index cases. This is achieved with population-wide child-parent screening. Integrated CPCS is currently better than either method of familial hypercholesterolaemia detection alone. It has the potential to identify all, or nearly all, individuals with familial hypercholesterolaemia in the population at low cost.

Scanning electron microscopy for blood micro-crystals in aortic stenosis patients.

BACKGROUND: Micro-crystals of calcium phosphate have been detected on the aortic valve of patients with aortic stenosis using scanning electron microscopy. It is not known whether crystalisation is specific to heart valve tissue or a general blood-derived process. METHODS: To this end we modified the method to determine whether calcium phosphate micro-crystals were present in the blood of patients with aortic stenosis. The method was first validated by adding synthetic calcium phosphate hydroxyapatite micro-crystals to healthy volunteer blood samples and determining the lower limit of detection. Then the method was used to examine the blood of 63 patients with echocardiographically confirmed aortic stenosis and 69 unaffected controls undergoing echocardiography for other reasons. Serum calcium and phosphate were measured and the calcium phosphate product compared in cases and controls. RESULTS: In the validation study, synthetic hydroxyapatite micro-crystals were identified down to a lower concentration limit of 0.008mg/mL. In the experimental study no particles were identified in any patient, with or without aortic stenosis, even though serum calcium phosphate was higher in cases compared with controls 2.6mmol/L (2.58-2.77) versus 2.47mmol/L (2.36-2.57), p = 0.005 for the difference. CONCLUSION: The results of our study confirm a positive association between serum calcium phosphate and aortic stenosis, but indicate that the calcium phosphate particles found in valve tissue do not precipitate freely in the blood.

The sternal wire code; Solving the problem of missing coronary artery bypass graft records during cardiac catheterization.

BACKGROUND: The sternal wire code records details of coronary artery bypass surgery (CABG) inside patients, based on the orientation of wires used for sternal closure. Visible on X-ray, the code overcomes the problem of missing graft-notes needed before repeat angiography. We determined (i) the potential value (ii) acceptability and (iii) accuracy of the code in practice. METHODS: (i) Consecutive coronary angiogram reports (2015-2016 Barts, London) were reviewed to identify patients with previous CABG and those with and without graft-notes before angiography. (ii) UK surgeons were surveyed on whether they would insert the code during CABG. (iii) A clinician, blinded to operative details, interpreted 16 post-CABG X-rays, 8 with the code and 8 without. RESULTS: (i) Of 6483 angiography patients, 559 had previous CABG (9.2% (8.5-10%)). Graft-notes were missing in 91/559 (15.1% (12-18%)); almost all (88/91) among patients with acute myocardial infarction. (ii) In the survey, 66/71surgeons (93% (84-98%)) were willing to use the code. (iii) In the accuracy test, all coded X-rays were identified and 28/28 grafts correctly interpreted (p < 0.001). CONCLUSIONS: About 1 in 6 patients with previous CABG, who require emergency coronary angiography, undergo this procedure without graft-notes and would benefit from the sternal wire code which appears clinically acceptable and accurate.

Association between serum calcium, serum phosphate and aortic stenosis with implications for prevention.

Background Aortic stenosis is the most common cause of valvular heart disease with no means of prevention. Lowering serum levels of calcium or phosphate are potential preventive strategies but observational studies on the associations with aortic stenosis are inconsistent. Design and methods A case-control study was conducted in 132 individuals undergoing echocardiography (63 with aortic stenosis and 69 without) and the results combined with three other comparable studies (914 individuals overall) to provide a summary odds ratio of aortic stenosis for a 0.1 mmol/L increase (approximately one standard deviation) in calcium and phosphate respectively. The relationship between calcium and phosphate and the severity of aortic stenosis, according to peak trans-aortic velocity, was also examined in the case-control study using linear regression. Results Both calcium and phosphate were positively associated with aortic stenosis. The summary odds ratio for a 0.1 mmol/L increase in calcium was 1.79 (95% confidence interval 1.07-2.99), p = 0.027 and for phosphate it was 1.47 (1.08-2.01), p = 0.015. Peak trans-aortic velocity increased with phosphate levels, 9% (4%-14%) per 0.1 mmol/L, p = 0.001, but not with calcium, p = 0.089. Conclusions If the associations are causal and reversible, these results indicate that a small reduction in calcium or phosphate levels, within the physiological rage, would translate into a clinically significant reduction in the risk of aortic stenosis. Randomised trials of calcium and phosphate lowering therapies in aortic stenosis are needed.

Watchful Waiting in Aortic Stenosis: The Problem of Acute Decompensation.

BACKGROUND: Acute decompensation with heart failure, angina, or syncope may be the first indication of undiagnosed aortic stenosis, but should be uncommon when the disorder is known and managed by watchful waiting. There is a lack of information on the proportion of patients with acute decompensated aortic stenosis with and without a prior diagnosis and their outcomes. METHODS: We examined the records of patients with aortic stenosis (International Classification of Diseases code 135.0) admitted to 3 UK hospitals between January 2015 and January 2016. We determined the number of admissions with acute decompensation and the proportion in whom aortic stenosis was and was not previously known. The characteristics and outcomes in the 2 groups were compared. RESULTS: Of 684 patients with aortic stenosis, 543 (79%; 95% confidence interval [CI], 76-82) were elective admissions and 141 (21%; 95% CI, 18-24) were emergencies with acute decompensation; 86 of 141 patients (61%; 95% CI, 52-69) with known aortic stenosis were under watchful waiting and 55 of 141 patients (39%; 95% CI, 31-48) did not have a prior diagnosis. In-hospital mortality was 16% versus 13%, respectively (P = .48). There were no statistically significant differences in characteristics or clinical presentation between the 2 groups (P > .1 for all comparisons). CONCLUSIONS: Approximately 1 in 5 patients admitted to the hospital with aortic stenosis have life-threatening complications due to their disorder. More than half of such patients are actively monitored for aortic stenosis before admission, exposing shortcomings of the watchful waiting management strategy. Measures to identify symptomatic patients earlier and shorten the time between symptom onset and surgery have the potential to substantially reduce morbidity and mortality.